Controlled discharge ostomy appliance and shield therefor

ABSTRACT

A controlled discharge ostomy appliance assembly comprises (i) a stoma seal that is self-urging with a dynamic damping characteristic that resists changes of seal volume, (ii) a press-fit coupling member displaceable from an unlocked position to a locked position as part of a press-fit process, and (iii) a single-use frangible portion. The assembly further includes a protector shield removably fastened to the appliance forming a combined assembly therewith. The protector shield comprises (i) a seal displacer manipulable for displacing the stoma seal to a non-operative position ready for fitting, (ii) a substantially rigid coupling member guard portion for protecting the state of the coupling member, and (iii) a bracing portion for bracing the single-use frangible portion.

CROSS-REFERENCE

This application is a continuation application of U.S. patentapplication Ser. No. 13/395,047, filed on Mar. 8, 2012, now U.S. Pat.No. 8,845,606, which is a U.S. National Phase of PCT/US10/48211, filedSep. 9, 2010, which claims the benefit of U.S. Provisional ApplicationNo. 61/276,352, filed on Sep. 11, 2009, each of which is entirelyincorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates to a controlled discharge ostomy applianceand an auxiliary device therefor. The auxiliary device may, for example,be a shield or packaging for the controlled discharge ostomy appliance.

BACKGROUND TO THE INVENTION

U.S. Pat. No. 6,723,079 and EP-A-1348412 describe controlled dischargeostomy devices including an inflatable membrane seal for creating atemporary conformal closure of the stoma. The inflatable seal comprisesa sealed chamber having an inflation port closed by a check valve. Afterhaving fitted the appliance at a stoma, the seal is inflated by couplingan external inflation source, for example a pump or a syringe, to thecheck valve. Once the inflation fluid has been injected into thechamber, the check valve seals the chamber preventing loss of inflationfluid and preserving the inflation state.

Such a system can be comfortable to fit and provide good sealperformance, but may require careful design. One design issue is theprovision of an external inflation source as a separate item carried bythe user, in order to be able to inflate the seal after having fittedthe appliance, or to top-up the seal with additional inflation fluid incase of fluid loss or stoma leakage. Another design issue is theimportance of keeping the contact pressure between the stoma and themembrane seal in a narrow range, namely as low as possible (to ensuregood blood perfusion in the stoma tissue) while maintaining an effectivetemporary seal against discharge of stool. However, it is difficult tokeep the contact pressure in such a narrow range because, for a givenamount of inflation fluid in the chamber, any change in chamber volumecaused by movement of stoma, directly affects the inflation pressure.During the wear time of an ostomy appliance, the stoma can movedynamically inwardly towards the body and/or outwardly away from thesurface of the peristomal skin over a total distance that can exceed 1cm. This movement can be due to peristaltic motion of the bowel,impending release of stool or gas from the stoma, or muscularcontractions of the abdomen. Under conditions when the stoma movesinwardly towards the body (i.e. increasing the volume of the inflationchamber), the contact pressure between the membrane seal and the stomacan fall, increasing the risk of leakage of stool if the contactpressure is too low. In contrast, under conditions when the stoma or itscontents pushes outwardly against the membrane seal (reducing the volumeof the inflation chamber), contact pressure between the seal and thestoma can potentially rise. During such times, the increased contactpressure may result in undesirable reduced blood perfusion in the stoma.The duration of such conditions may be highly unpredictable, somelasting only seconds, others minutes, and sometimes several hours.

International patent application publication no. WO 2009/029610describes an alternative seal that is both self-compensating andself-urging towards the stoma. The seal comprises a fluid chamberincluding a fluid impermeable membrane that forms a movable wall of thefluid chamber, one or more fluid flow regulation ports communicatingwith the chamber; and resilient foam disposed within the fluid chamber.With such a seal, the contact pressure between the seal and the stomahas both a static component and a dynamic component. The staticcomponent comes from the foam, which is compressed by the seal bearingon the stoma, and applies a resilient return force on the stoma. Thefoam is configured so that the static component of the contact pressureis always within the narrow range of acceptability explained above. Thedynamic component of the contact pressure results from the portregulating fluid flow to and from the chamber, as the chamber volumeadapts to follow any movement of the stoma. The port defines a dynamicdamping characteristic of adaptation of the seal, in addition to theeffect of the foam.

Such a self-urging design has the potential advantage that no externalinflation source is needed, thereby avoiding the user having to carrysuch a separate device. The pressure inside the seal is self-regulating,and the seal can adapt to different volumes automatically. While thefoam permits a wide range of stoma shapes and sizes to be accommodated,the dynamic damping characteristic resists compression of the sealshould the stoma begin to push outwardly. The fluid trapped in thechamber by the damping characteristic generates a temporary, dynamicincrease in the contact pressure exerted by the seal to counter such achallenge from the stoma. A transient challenge may be caused by stooland flatus in the stoma, and the temporary increase in sealing pressureenhances the seal against escape of stool, without the increased sealingpressure being exerted for too long to obstruct regular blood perfusionof the stoma. The damping characteristic only temporarily trapsinflation fluid, thereby allowing the seal to adapt in volume if theoutward movement of the stoma is more than transient.

US-A-2007/088300 describes a single-use ostomy appliance including anostomy coupling for releasably coupling first and second portions at astomal orifice. The two portions may be separable body-side andnon-body-side parts, or the two portions may be portions of a unitaryostomy device such as a controlled evacuation device. The couplingincludes a mechanical fastener configured such that the coupling isrendered substantially not resecurable after the fastener is released.

US-A-2007/129695 describes an ostomy coupling including a body-sidecoupling member, an appliance-side coupling member including pluralfastener lugs, and a bracing member. The lugs flex independently of eachother to provide plural independent latching fastenings. The bracingmember is moved between a bracing position in which the bracing memberlocks the lugs by resisting flexing movement, and a non-bracing ordis-mounted position in which the lugs are free to flex. The ostomycoupling is used with an ostomy pouch or with a controlled dischargeostomy appliance.

The present invention seeks to further enhance versatility and ease ofuse of controlled discharge ostomy appliances.

SUMMARY OF THE PRESENT INVENTION

Aspects of the invention are defined in the claims.

Broadly speaking, a first aspect of the present invention is based on asurprising appreciation that the desirable damping characteristic of theself-urging seal described above, becomes an unwanted hindrance whenfitting the appliance to a stoma. The natural shape of the self-urgingseal when not in contact with the stoma is a fully distended form,projecting significantly more than the shape when in contact with astoma. During the fitting process, as the appliance is pressed towardsthe skin, the seal contacts the stoma and compresses dynamically, andsignificantly in volume, to conform to the stoma shape. The problem isthat the damping characteristic is designed specifically to resist suchdynamic compression of the seal, and instead to generate a counter forcepressing on the stoma. This can result in three issues:

(i) the resistance to dynamic compression results in an initially highcontact pressure against the stoma, which can be significantly higherthan that normally expected when in an operative state. The high contactpressure makes fitting uncomfortable, and the discomfort can last beyondthe fitting stage until sufficient time has passed for the dynamicdamping effect to have eased, and pressure balance to be achieved;

(ii) the final shape adopted by the seal might not be that matching anatural shape of the stoma, because both the seal and the stoma aresubjected to the high contact pressure. This may reduce the efficacy ofthe seal; and

(iii) the reaction force in the seal is in turn supported through anadhesive attachment between the appliance and the skin. The greatercontact pressure on the stoma results in a greater reaction force,placing additional stress on the adhesive attachment, which can begreater than that normally encountered once in the operative state. Theadditional stress may risk weakening the adhesive attachment, orincrease the risk of leakage. With the appliance in place, it isdifficult if not impossible to observe or verify the state of theadhesive attachment, and so this problem may go unnoticed.

The above issues may be mitigated by reducing the damping characteristicof the seal to allow the seal to change shape more readily. However,reducing the damping characteristic is undesirable, because the sealthen has less ability to resist an outward challenge from the stoma.Thus we have discovered that there is an inherent incompatibilitybetween a desirably high damping characteristic that enhances dynamicseal performance in use, and a requirement for a small dampingcharacteristic to facilitate initial fitting of the appliance at astoma.

The first aspect of the invention provides a different approach for acontrolled discharge ostomy appliance including a self-urging seal. Asused herein, a self-urging seal means, for example, a seal that does notrequire an external source, such as an inflation pump or syringe, togenerate a sealing force or urging force towards the stoma. Theself-urging seal may optionally include a resilient component (e.g. aresilient device or member) for generating a sealing or urging force,and/or a damping device for damping displacement of the seal in additionto the effect of the resilient member. The invention involves placingthe seal in (or displacing the seal to) a non-deployed state prior tofitting the appliance. Displacing the seal against the urging forceprior to fitting avoids the stoma being subjected to the seal'sresistance to compression at the time of fitting. In the non-deployedstate there is substantially no contact between the seal and stoma (orat least less contact compared to a fully deployed state of the seal).Once released, the seal begins to deploy automatically under the seal'sown self-urging effect.

If the self-urging seal has a dynamic damping characteristic, not onlydoes the above technique avoid high contact pressure being exerted onthe stoma during fitting, but the initial contact pressure can be evensmaller than would be exerted by the resilient member alone. This isbecause the damping characteristic may also act in reverse, damping orslowing movement of the seal from the non-deployed state towards thestoma. The full force from the resilient foam is only exerted when theseal has deployed and reaches pressure balance.

In addition to more comfortable fitting, deploying the seal into contactwith the stoma from a non-deployed condition may achieve a betterfitting shape of the seal, than if the seal is forced to compress whenfitted in a fully-deployed condition. It is believed that this betterfitting shape may be a result of (i) the seal being able to drape aroundthe stoma more freely as contacts the stoma progressively duringdeployment, and/or (ii) avoiding or reducing the extent to which thestoma is itself deformed from its natural shape by contact pressure onthe stoma.

The seal may be placed in the non-deployed state at any time between,and inclusive of, manufacture and immediately prior to fitting of theappliance. In one form, it is preferred that the seal be displaceable tothe non-deployed state by a user at a time chosen by a user, forexample, shortly before fitting.

A seal displacer is coupled releasably (or coupleable releasably) to theappliance. For example, the seal displacer is coupled by means of amechanical or adhesive fastener, to form a combined assembly with theappliance. The fastener may interlock with, or otherwise attach to, anostomy coupling member of the appliance intended for mounting theappliance in an operative position at a stoma. Alternatively, thefastener may interlock with, or otherwise attach to, a portion of theappliance distinct from the ostomy coupling member. The portion of theappliance may, for example, be a periphery of a housing or cover of theappliance. Avoiding attachment to and/or contact with the ostomycoupling member preserves the state of the ostomy coupling member untilfirst use.

In a preferred form, the seal displacer is manipulable by a user todisplace the seal to the non-deployed position at a time chosen by theuser. The seal displacer may be comprised in an auxiliary device for theappliance. The auxiliary device may, for example, be in the form of aprotector or shield or other packaging for the appliance. Use of theseal displacer enables the seal to be manipulated with the protectorstill assembled to the appliance, thereby avoiding risk of soiling ordamaging the seal surface. The seal displacer is releasable from theappliance, whereupon the seal begins to deploy under the seal'sself-urging effect.

The seal displacer is preferably displaceable between a first limitposition, in which the seal displacer accommodates the seal in a (atleast near) fully deployed shape to which the seal distends naturally,and a second limit position corresponding to the non-deployed state ofthe seal. The first limit position may optionally define a cup shape forreceiving the seal, and/or the second limit position may optionallydefine a counter-cup shape with an opposite convexity to the first limitposition. Additionally or alternatively, the seal displacer may beconfigured to be generally bistable, adopting stably either one of thelimit positions.

The seal displacer may be configured to cover substantially all, or atleast a majority of, the otherwise exposed surface of the seal. The sealdisplacer may extend across the otherwise exposed surface, from oneperipheral portion of the seal to an opposite peripheral portion.

The seal preferably has a damping characteristic such that the sealdeploys progressively from the non-deployed state once released. Thedeployment interval (the time taken to deploy from the non-deployedstate to a full deployed state) may be at least 1 minute, or at least 2minutes, or at least 3 minutes, or at least 4 minutes, or at least 5minutes, or at least 10 minutes. The deployment interval is preferablysufficient to provide the user with sufficient time to fit the applianceat the stoma, before the seal deploys significantly towards an operativestate. The seal reaches full deployment against the stoma only afterfitting of the appliance has been completed, and the appliance isalready in its fitted condition.

Broadly speaking, a second aspect of the invention relates to fitting ofa controlled discharge ostomy appliance using a separate body fitmentworn on the body. The second aspect may provide a controlled dischargeostomy appliance for attachment to a counterpart coupling element. Thecounterpart coupling element may, for example, be part of an adhesivebody-fitment wearable on the body around the stoma. The appliancecomprises:

a first member of closed loop form and including a coupling formationfor making a press-fit engagement with a said counterpart couplingelement when the two are pressed together in a first direction, thecoupling formation being deflectable or capable of flexing to permit thepress-fit engagement;

a second member having at least one bracing portion;

the first and second members being relatively displaceable in (orgenerally parallel to) said first direction, from a first unlockedposition in which the bracing portion does not substantially brace thecoupling formation against said displacement, to a second lockedposition for (directly or indirectly) bracing the coupling formation ofthe first member against said displacement;

co-operating retainers on the first and second members for:

(i) retaining said first and second members initially in said unlockedposition with a first retention strength until pressure is applied tocause relative displacement of the first and second coupling members tothe locked position; and

(ii) retaining said first and second members in said locked positionwith a second retention strength (optionally greater than said firstretention strength).

The appliance optionally further includes a single-use feature forobstructing attachment of the device to a said counterpart couplingelement more than once. Preferably, the single-use feature comprises afrangible portion of the second member. In order to detach the deviceafter a first use (or first attachment), the frangible portion of thesecond coupling member is configured to be at least partially torn orbroken, thereby releasing the bracing effect of the bracing portion.Thereafter, the second member is substantially incapable of bracing thecoupling formation (at least to the same degree as the firstattachment).

The counterpart coupling element may be configured such that theassembly force required to press-fit engage with the coupling formationof the first member, is less than the first retention strength.

Prior to first use, the first and second coupling members are retainedin the unlocked position by the co-operating retainers. Upon first use,in order to assemble the appliance to the counterpart coupling element,the appliance is pressed against the counterpart coupling element. Thepress-fit coupling force being smaller than the first retention strengthgenerally encourages a two-stage engagement effect. The counterpartcoupling element is able to engage the coupling formation generallyprior to the pressure causing relative displacement between the firstand second members to the locked position. Once in the locked position,the bracing portion of the second member braces the coupling formationagainst deflection, thereby locking or securely attaching the applianceto the counterpart coupling element. In order to separate the appliance,the frangible portion is torn or broken, releasing the bracing effect.The first member may remain at least temporarily coupled to thecounterpart coupling element, at least until an external force isapplied to separate the two. However, the release of the bracing effectmeans that it becomes easier to separate the first member from thecounterpart coupling element. Optionally, the second member may be movedaway from the first member, exposing the first member and facilitatingseparation. The second member may be shaped or configured so as to atleast partly shroud the first member at least when in the lockedposition.

The first and second aspects may be used independently of each other, oradvantageously in combination.

A third aspect of the invention relates to an auxiliary device for acontrolled discharge ostomy appliance. Whether or not the applianceincludes a self-urging seal, and/or a coupling member initially held inan unlocked position, and/or a single-use feature, the fourth aspectprovides a protector of molded plastics, the protector being configuredto be releasably coupled to the appliance to form a combined assemblytherewith, for protecting the body-facing portion of the appliance priorto use of the appliance.

The body-facing portion of the appliance typically includes at least astoma seal for sealing engagement with a stoma in use, and a mountingdevice for mounting the appliance in an operative position at a stoma.The seal is, by its nature delicate and vulnerable to damage. Damage tothe seal surface may reduce the efficacy of the stoma seal, and lead topremature leakage of stool during the normal wear-life of the appliance.The protector can also keep the surface of the seal clean, whileenabling the appliance (with the protector assembled thereto) to becarried in a suitable bag, such as a hand-bag or brief-case, untilfitted.

The protector optionally includes at least one of:

(i) a seal displacer manipulable by a user to displace a self-urgingseal of the appliance to a non-deployed position prior to fitting theappliance at a stoma;

(ii) a substantially rigid coupling member guard portion for protectinga first member of the appliance from external forces that mightotherwise push the first member from a unlocked position to a lockedposition;

(iii) a bracing portion for bracing and supporting a second member ofthe appliance, the second member including a frangible portion that isselectively breakable or tearable in use to release the appliance;

(iv) a fastener profile for cooperating with a periphery of theappliance, to couple the protector to the appliance to form a combinedassembly therewith.

The protector may be configured to extend over and/or substantiallycover a body-facing side of the appliance. The protector may have theform of a half-shell. The protector may include one or more concave ordished portions.

The seal displacer may be located at a centre of the protector.

The rigid guard portion may comprise a channel shaped fender, the fenderextending in a closed loop to define an endless channel. The rigid guardportion may be reinforced, for example, by one or more ribs.

If the seal displacer and the rigid guard portion are both provided, therigid guard portion may extend around the seal displacer. The rigidguard portion and the seal displacer may adjoin at, or be separated by,an interface profile that permits displacement of the seal displacerwithout substantial displacement of the rigid guard portion. Theinterface profile may, for example, comprise one or more folds,corrugations or pleats in the plastics material.

The bracing portion may comprise a step shaped recess in the protector,and extending around a closed loop shaped path.

The fastener profile may comprise one or more undercut lugs.

The protector may have a surface profile on one side that is generallythe negative of the profile of the surface of the other. The protectormay be made of plastics material that is sufficiently stiff to define aself-supporting shape, but is flexible to permit limited deformation(for example, for the seal displacer, and to permit the protector to beseparated from the appliance). The protector may for example, be made ofblow-molded, or vacuum-molded plastics.

In a related fourth aspect, the invention provides a plastics protectorfor a controlled discharge appliance, the protector comprising: anencircling rim portion disposed near or at the periphery of theprotector; an annular step portion radially inwardly of the rim portionand extending towards a first side of the protector; an annular channelportion radially inwardly of the annular step portion, and extendingfurther to said first side than the step portion; and a displaceablebutton portion disposed radially inwardly of the channel portion. Thedisplaceable button portion may be less rigid than at least the channelportion. The channel portion may define a protection fender. Thedisplaceable button portion may be joined to an inner wall of thechannel portion via an interface region that permits manipulation of thebutton portion without substantial deformation of the channel portion.The displaceable button portion may be generally central, and the otherportions arranged progressively outside the button portion.

In a related fifth aspect, the invention provides a controlled dischargeostomy appliance, the appliance comprising:

a first integrated module comprising: a top wall; a collapsiblecollector depending from the top wall at a first open end of thecollector; and a first member of closed loop shape depending from thecollapsible collector at a second open end of the collector; the firstmodule defining a first chamber;

a second integrated module comprising: a second member including abracing portion for cooperating with the coupling formation of the firstmember for bracing the coupling formation against outward deflection,the second member including a frangible portion for releasing thebracing effect when the frangible portion is broken; and

a third integrated module comprising: a seal support wall and a sealmembrane depending from the seal support wall, the seal support wall andthe seal membrane defining a seal chamber in which is disposed aresiliently compressible component (e.g., a device or material); thethird module being locatable in an operative position at least partlywithin in the first chamber of the first module with the seal supportwall arranged close to the top wall.

The second member and/or module may generally have a closed loop form,and define a skirt profile around the first module. At least a portionof the top wall of the first module may be received in or at arespective aperture of the second member.

The second module is typically an integrally molded item consisting ofthe second member. The frangible portion may be defined by a line orregion of relative weakness. In use, when a user tears or breaks thefrangible portion, this may split the closed loop shape of the secondmember, breaking the loop into a discontinuous form.

The seal support wall may comprise or carry one or more ports forcontrolling fluid flow into and/or our of the seal chamber. At least oneport may comprise a chimney that extends through an aperture in the topwall (when the modules are assembled together). Additionally oralternatively, at least one (other) port may communicate with a spacebetween the seal support wall and the top wall (when the modules areassembled together).

The top wall (of the first module) and the seal support wall (of thethird module) may together define a flatus vent space communicating withthe first chamber around at least a portion of the periphery of the sealsupport wall. A deodorising filter and/or a phase separator may bedisposed in the flatus vent space. When both are provided, the phaseseparator preferably shrouds the deodorising filter. The phase separatormay, for example, comprise open cell foam, or some other material thatallows passage of flatus while resisting passage of at least semi-solid(and optionally liquid) waste.

A coupling is provided for retaining the third module in the operativeposition with respect to the first module, optionally in conjunctionwith the second module. The coupling may comprise elements configured toform an interference (e.g. interlocking or tight friction) fit. Theelements may include cooperating lugs on the seal support wall and thetop wall, and/or inter-fitting surfaces of the chimney and therespective aperture of the top wall through which the chimney passes.

A coupling is additionally provided between the second module and atleast one of the first and third modules, for retaining the modules inassembled condition. The coupling may comprises elements configured toform an interference (e.g. interlocking or tight friction) fit.

In a further aspect, a controlled discharge ostomy appliance assemblycomprises (i) a stoma seal that is self-urging with a dynamic dampingcharacteristic that resists changes of seal volume, (ii) a press-fitcoupling member displaceable from an unlocked position to a lockedposition as part of a press-fit process, and (iii) a single-usefrangible portion. The assembly further includes a protector shieldremovably coupled to the appliance forming a combined assemblytherewith. The protector shield comprises (i) a seal displacermanipulable for displacing the stoma seal to a non-operative positionready for fitting, (ii) a substantially rigid protection portion forprotecting the state of the coupling member, and (iii) a bracing portionfor bracing the single-use frangible portion.

The above aspects may be used independently of each other ofadvantageously in combination. Various additional or alternativefeatures, objects and advantages of the invention will be apparent tothe skilled person from the following detailed description. Protectionmay be claimed for any novel feature or idea disclosed herein and/or inthe drawings, whether or not emphasis has been placed thereon.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic section through a preferred embodiment ofcontrolled discharge ostomy appliance, with a shield protector inexploded view.

FIG. 2 is a schematic exploded perspective view of the components ofFIG. 1.

FIG. 3 is a schematic section similar to FIG. 1, showing the protectorshield fitted to the appliance as a combined assembly prior to fitting.

FIG. 4 is a perspective view from above of the components of FIG. 3.

FIG. 5 is a schematic section illustrated displacement of the seal to anon-deployed position, using the protector shield, prior to fitting.

FIG. 6 is a schematic section showing separation of the shield protectorfrom the appliance.

FIG. 7 is a schematic section showing fitting of the appliance at astoma with the seal in the non-deployed state.

FIG. 8 is a schematic section showing the seal reaching a deployed stateafter initial fitting of the appliance.

FIG. 9 is a schematic section and exploded view of the appliance,illustrating a relation between an appliance coupling member, and abody-side fitment.

FIG. 10 is a schematic underside perspective view of the appliancecoupling member in isolation.

FIG. 11 is a schematic section along the line XI-XI of FIG. 10, on anenlarged scale.

FIG. 12 is a schematic section showing on an enlarged scale a detailfrom an encircled portion of FIG. 1, and showing approach of theappliance coupling member to a body-side coupling member (shown inphantom).

FIG. 13 is a schematic section similar to FIG. 12, but showing a firststage of engagement with the body-side coupling member (shown inphantom), with the appliance coupling member in the unlocked position.

FIG. 14 is a schematic section similar to FIG. 12, but showing a secondstage of engagement with the body-side coupling member (shown inphantom), with the appliance coupling member displaced to the lockedposition.

FIG. 15 is a schematic section showing, in exploded view, a modularconstruction of the appliance.

FIG. 16 is a schematic exploded view illustrating the components of thethird module.

FIG. 17 is a schematic perspective view showing the second and thirdmodules of the appliance.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The following description refers to all of the drawings, althoughcertain drawings are selected to highlight the described features. Thesingle preferred embodiment embodies multiple aspects of the invention,as described individually below. These aspects may be used independentlyof each other, or advantageously in combination as in the illustratedform.

Displacement of Seal Prior to Fitting Appliance at Stoma

A first aspect used in the preferred embodiment is provision for theseal to be displaced to make the appliance ready for fitting.

Referring to the drawings, a controlled evacuation ostomy appliance 10is illustrated for controlling discharge from a wearer's stoma 12 (FIGS.7 and 8). The appliance 10 generally comprises a cover 14, a stoma seal16, and a mounting device 18. While FIG. 1 shows these features asdistinct items for ease of understanding, it will be appreciated thateach feature may be made of several components, and that portions ofplural features may be integrated together.

The stoma seal 16 is configured for sealing internally and/or externallyagainst the stoma 12, in order to obstruct discharge of body waste. Theseal 16 may be configured to obstruct discharge of at least solid waste,more preferably also semi-solid and/or liquid waste. The seal 16 may beconfigured to allow flatus gas to escape from the stoma 12, in order toavoid flatus accumulating uncomfortably within the stomal tract.Discharged flatus passes through a deodorising filter 20 and is ventedto atmosphere via one or more outlet apertures 22 in the cover 14.

The seal 16 is of a self-urging type, which generates an urging force toapply a sealing force to the stoma. The term self-urging means that,once fitted and in use, the seal (or the appliance) generates its ownurging force towards the stoma without reliance on application of apressurization force from a source external to the appliance 10 (forexample, using an external inflation pump, or applying a physicalpumping force to the appliance). In the present embodiment, the seal 16comprises a flexible membrane 24, and a resilient component 26 forurging the flexible membrane towards the stoma 12 in use. The resilientcomponent 26 may take a variety of forms, such as a compressible fluid,and/or a member of resilient material. In the preferred form, theresilient component 26 comprises a member made of resilientlycompressible plastics foam. The foam may be open cell foam. Suitablefoam materials include polyurethane, cellulose, or olefin. Closed cellfoams may also be desirable. An optimum three-dimensional form of thefoam member is discussed later in relation to FIG. 16. The resilientcomponent 26, when compressed, generates or maintains a return force onthe membrane 24, thereby providing at least a component of the sealingpressure in use. The resilient component 26 may be supported by asupport wall 28 of, or attached to, the cover 14.

The seal 16 further comprises a damping device that damps or resistscertain motion or displacement of the membrane 24. The damping devicemay comprise a damping chamber 30 for damping fluid. The damping chamber30 may accommodate the resilient component 26. The membrane 24 may format least a portion of the wall of the damping chamber 30. A suitabledamping fluid is, for example, air. The chamber 30 further comprises oneor more ports 32 a and 32 b for controlling admission and/or dischargeof the damping fluid into/from the damping chamber 30. For example, theport(s) 32 a and 32 b may restrict the rate of flow of damping fluidthrough the port (in a specific admission or discharge direction, or inboth admission and discharge directions). Restricting the rate of flowof damping fluid slows the rate of changes in volume of the chamber 30,and hence damps motion of the membrane 24. Restricting admission ofdamping fluid through the port(s) 32 restricts the rate at which theseal 16 can expand to urge the membrane 24 against the stoma 12.Additionally or alternatively, restricting discharge of damping fluidthrough the port(s) 32 a and 32 b restricts the rate at which the seal16 can shrink and/or move in a direction away from the body in use.

A variety of different configurations for the port(s) 32 a and 32 b arepossible, to provide a variety of different possible dampingcharacteristics. The damping characteristic may result from a compoundeffect of plural ports functioning in parallel with each other. Ingeneral, a desirable damping characteristic is one that comprises: (i) arestriction to admission of inflation fluid, to slow expansion ormovement of the seal towards the stoma; (ii) a restriction to dischargeof damping fluid, to slow compression or movement of the seal away fromthe stoma; and (iii) a pressure-relief effect to allow substantiallyunrestricted discharge of damping fluid should the pressure within theinterior of the damping chamber 30 exceed the pressure outside thechamber by a predetermined threshold. The threshold may, for example, beat least 75 mmHg. The restriction to admission (i), and the restrictionto discharge (ii), may be substantially equal to each other, or may bedifferent in magnitude. In either case, both restrictions (i) and (ii)may be provided in common by a bidirectional port. Alternatively, therestriction to admission (i) and the restriction to discharge (ii) maybe implemented by distinct unidirectional ports. The pressure-reliefeffect may be provided by an additional pressure-relief port, or it maybe provided as an additional valve function of one of the other valves.

A highly practical configuration is a first port 32 a that has abidirectional characteristic that acts as a restriction to fluid flow inboth the admission and discharge directions, to substantially the samedegree. The first port 32 a may be implemented by a piece of porous(e.g. microporous) material. The first port may define an airflow rateof between 0.1 cc/min and 15 cc/min under an applied pressure of between5 mmHg and 40 mmHg. A second port 32 b provides the pressure-relieffunction, the second port 32 b comprising a valve that opens to create asubstantially non-restricted path to discharge of fluid from the chamber30 when the fluid pressure within the chamber 30 exceeds the externalpressure by more than the aforementioned threshold.

At least one of the ports (here 32 a) may communicate directly with theatmosphere outside the appliance. Additionally or alternatively, atleast one of the ports (here 32 b) may communicate directly with thespace containing the flatus vent filter 20, such that the portcommunicates indirectly with external atmosphere via the filter 20.

The appliance 10 is initially fitted with a protector 40 that protectsthe body-side facing components of the appliance 10 prior to theappliance 10 being used. The protector 40 typically has the form of ashield, or another shape that follows the shape of the body-side face ofthe appliance. The protector 40 extends to cover substantially theentire body-side facing side of the appliance 10. The protector 40 mayalso encapsulate a peripheral edge of the appliance, in order to protectthe appliance from side impacts. The protector 40 is releasably coupledto the appliance 10 by means of protector fastener lugs 42 that engagethe periphery of the appliance 10 (e.g. the periphery of the cover 14)to form a combined assembly. Although the present embodiment illustratesa mechanical interfit by the protector fastener lugs 42, an adhesivefastener could be used alternatively or in addition.

The protector 40 comprises one or more sections selected from: aperipheral rim 44, an annular step 46, and a seal displacer 48.Optionally for this aspect, a substantially rigid mounting device guardportion (also referred to as a coupling member guard portion) 49 mayalso be provided for protecting the mounting device 18. Whether or notthe rigid guard portion 49 is used, it may be seen that the protectorfastener lugs 42 engage a portion of the appliance that is distinctfrom, and preferably also clear of, the mounting device 18. This canavoid stress on, or use of, the mounting device 18 prior to fitting theappliance at a stoma, so that the mounting device 18 is preserved in anoptimum state for use.

The present embodiment comprises all sections, the annular step 46extending radially inwardly of the rim 44, and the seal displacer beingdisposed radially inwardly of the step 46. The different sections areintegrally formed as a one-piece plastics molding. The plastics moldingmay, for example, be vacuum molded or blow molded. The lugs 42 projectinwardly from the rim 44, and define undercuts with respect to theannular step 46. The seal displacer 48 is generally centrally disposed,so that it is generally aligned with the seal 16 of the appliance 10. Aswell as protecting the seal 16, a significant function of the sealdisplacer 48 is to control or set the state of the seal 16.

In the present embodiment, the seal displacer 48 is molded to have aninitial shape (FIGS. 1-4) that corresponds to, or at least accommodatesor at least partly receives, the seal 16 when in a (near) fullydistended state. The fully distended state is the state in which theseal membrane 24 is fully distended or expanded by the resilient device26. The seal displacer 48 may accommodate the seal 16 in the fullydistended state, or the seal displacer 48 may accommodate the seal 16 ina near fully distended state (e.g. a distended state that is similar tothe fully distended state, even if the seal 16 is slightly compressed).The seal displacer 48 comprises a dished or cup section defining apocket for cupping or receiving at least a portion of the seal 16.

Referring to FIG. 5 at some time prior to fitting the appliance 10 at astoma, the user (or other caregiver) presses the stoma displacer 48 todisplace the seal 16 to a non-deployed state. Displacing of the sealcauses the seal to compress or retract to a position and/or shape inwhich the seal 16 will not initially contact the stoma 12 when theappliance is fitted. Typically the user displaces the seal just prior tofitting the appliance 10, but the user could also displace the seal evenearlier. As indicated in FIG. 5 by the arrows, the user may squeeze theappliance 10 with its protector 40 from above and below, for example,between opposed fingers and thumbs. The seal displacer 48 of theprotector 40 deforms to displace the seal 16, while the protector 40remains coupled to the appliance 10.

Although the port 32 a tends to restrict discharge of fluid from thechamber 30, as soon as the pressure within the chamber exceeds thethreshold, the second port 32 b opens to allow fluid discharge from thechamber 30. As explained above, the threshold is relatively modest, andis easily exceed by manual application of finger pressure squeezing theseal. Therefore, provided that the user is reasonably dextrous and ableto apply modest finger pressure to the seal displacer, the second port32 b will open to allow the seal 16 to be compressed readily withoutsignificant damping resistance. The seal displacer 48 may function toretain the seal 16 in its non-deployed state until the protector 40 isremoved.

Referring to FIG. 6, the appliance 10 is separated or ejected from theprotector 40. Typically, separation occurs once the seal 16 has beendisplaced. In the present embodiment, when pressure is applied betweenopposed fingers and thumbs, the seal 16 displaces progressively until itreaches its non-deployed state whereupon the pressure applied to theprotector 40 then flexes the protector, releasing the fasteningengagement between the lugs 42 and the cover 14 at least at one pointaround the periphery (and optionally all around the periphery). Theseparation of the appliance 10 from the protector is therefore aseamless part of the same operation as soon as the seal reaches itsnon-deployed state. In other embodiments, the protector 40 may beconfigured to remain fastened to the appliance 10 even once the seal 16has been displaced to its non-deployed state, until some additionalmanipulation is made to release the engagement between the fastener lugs42 and the cover 14.

Referring to FIG. 7, once the appliance 10 has been separated from theprotector 40, the action of the seal displacer 48 on the seal 16 isremoved, and the seal 16 tends to re-expand under the influence of theresilient device 26 inside the seal 16. The port 32 a restricts the rateat which fluid can re-enter the chamber 30, thereby damping movement ofthe seal 16 and slowing the speed at which the seal membrane 24 canre-deploy towards its fully distended state. Preferably, once releasedfrom the non-deployed state, the seal 16 may expand relatively slowlyover a period of a few minutes towards its fully deployed state, eventhough the resilient device 26 may itself tend to decompress over amatter of seconds were the damping effect to be removed. The port 32 amay be configured such that the deployment time from non-deployed tofully deployed may be at least 1 minute, or at least 2 minutes, or atleast 3 minutes, or at least 4 minutes, or at least 5 minutes, or atleast 10 minutes.

The above arrangement gives the user sufficient time to fit theappliance 10 at the stoma 12 before the seal 16 advances significantlytowards its deployed state. The appliance 10 is fitted in position usingthe mounting device 18. In the present embodiment, the appliance 10 isconfigured to be mounted to a body fitment 50 that is already worn onthe body around the stoma 12. The body fitment 50 typically comprises anapertured pad of medical-grade skin-friendly adhesive 52, and abody-side coupling member 54 of closed loop shape surrounding the padaperture. The mounting device 18 comprises an appliance-side (first)coupling member configured to form a mechanical (e.g. interference-fitor interlocking-fit) or adhesive coupling engagement with the couplingmember 54. The coupling engagement may be releasable to enable theappliance 10 to be separated from the body fitment 50 after use, whilethe body fitment remains in situ on the body around the stoma 12.Alternatively (not shown), the mounting device 18 may be configured tomount the appliance 10 directly on the body instead of mounting to abody fitment 50 already worn on the body. In such case, the mountingdevice 18 may include a pad of adhesive equivalent to the adhesive 52described above.

As depicted in FIG. 7, at the time of fitting, the seal membrane 24 isat or near its non-deployed position, out of contact with the stoma 12.The potential discomfort resulting from high contact pressure on thestoma 12 at fitting is therefore avoided. Also, the potential risk of ahigh reaction force weakening the adhesion between the body fitment 50and the peristomal skin, is also avoided.

Referring to FIG. 8, once the appliance 10 is fitted at the stoma 12,the seal 16 continues to advance or expand progressively towards thestoma 12 under the urging force of the resilient device 26. At some timeshortly after fitting (e.g. between 0.5 minutes and 10 minutes), theseal membrane 24 advances slowly into contact with the stoma 12, andconforms to the shape of the stoma 12. The initial contact pressurebetween the membrane 24 and the stoma 12 is less than would be appliedby the resilient device 26 alone. This is because the damping effect ofthe port 32 a resists the urging effect of the resilient device 26,thereby reducing the force applied to the membrane 24 by the resilientdevice 26. Once the seal 16 has fully conformed to the shape of thestoma 12, the chamber 30 reaches pressure equalization with externalatmosphere, and the chamber volume 30 stabilizes. As the seal 16approaches pressure and/or volume stabilization, the dynamic dampingeffect fades, and the contact pressure between the membrane 24 and thestoma 12 reaches that exerted by the resilient device 26. Deploying theseal 16 from a non-deployed condition enables the seal 16 more easily toconform to a natural shape of the stoma 12. Such a seal 16 can beextremely effective.

The contact pressure between the seal 16 and the stoma 12 comprises astatic component and a dynamic component. The static component isgenerated by the resilience of the resilient device 26 that remainspartly compressed by conforming to the stoma shape, and applies aresilient return force towards the stoma 12. The resilient device 26 isconfigured such that the passive component of the contact pressure doesnot exceed a predetermined limit value that might otherwise result inreduced blood perfusion in the stoma 12. For example, the predeterminedlimit value may be about 25 mmHg. The dynamic component of the contactpressure results from the port 32 a regulating fluid flow to and fromthe chamber 30 of the seal 16, as the chamber volume adapts to followany movement of the stoma 12. The port 32 a defines a dynamic dampingcharacteristic of adaptation of the seal, in addition to the effect ofthe resilient device 26. During expansion of the seal 16, the dynamiccomponent is negative, reducing the contact pressure (as explained aboveduring deployment of the seal); during compression of the seal 16, thedynamic component is positive, increasing the contact pressure. Such aself-urging design has the advantage that no external inflation sourceis needed, thereby avoiding the user having to carry such a separatedevice. The pressure inside the seal 16 is self-regulating, and the seal16 can adapt to different volumes automatically. While the resilientdevice 26 permits a wide range of stoma shapes and sizes to beaccommodated, the dynamic damping characteristic resists compression ofthe seal 16 should the stoma 12 begin to push outwardly. The fluidtrapped in the chamber 30 by the damping characteristic generates atemporary, dynamic increase in the contact pressure exerted by the seal16 to counter such a challenge from the stoma. A transient challenge maybe caused by stool and flatus in the stoma, and the temporary increasein sealing pressure enhances the seal 16 against escape of stool,without the increased sealing pressure being exerted for too long toobstruct regular blood perfusion of the stoma. The dampingcharacteristic only temporarily traps inflation fluid, thereby allowingthe seal 16 to adapt in volume if the outward movement of the stoma 12is more than transient. The pressure relief port 32 b provides a furtherdegree of security to ensure that the pressure in the chamber 30 doesexceed the pressure relief threshold, even when the additional dynamiccomponent is significant. The pressure relief port 32 b opens to ventinflation fluid should the pressure relief threshold be exceeded.

The technique of displacing the seal 16 to a non-deployed position priorto fitting the appliance, enables the dynamic damping effect to be usedadvantageously both during fitting, as well as in use, of the appliance10.

Displaceable Appliance Coupling Member

A second aspect of the preferred embodiment relates to a coupling memberarrangement for making a press-fit with a body-side coupling member forfitting the appliance at a stoma. This aspect may be used in combinationwith the first aspect, or independently of the first aspect. Thefollowing description focuses on a coupling for the appliance, but thisembodiment may also use any combination of features from the firstembodiment as if described in whole combination.

As best seen in FIGS. 9-11, the mounting device comprises a first member(first coupling member or appliance-side coupling member) 18 distinctfrom the cover 14 (second member). The first member 18 is of closed loopshape (e.g. annular in this embodiment). The first member 18 has a base70 carrying a coupling formation for mechanically engaging the body-sidecoupling member 54 of the body fitment 50. The coupling formationcomprises a plurality of lugs 72 depending from the base 70 at spacedapart positions around the periphery of the base 70. Each lug 72 has aradially inwardly projecting, undercut tooth 74 near its tip. The tooth74 is configured for mechanically engaging a bead 58 of the body-sidecoupling member 54. Each lug 72 is able to flex, or deflect from itsnormal position, with respect to the base 70, independently of otherlugs 72 to permit engagement and disengagement of the body-side couplingmember 54. Each lug 72 may include a hinge or pivot portion 76 (FIG. 8)about which flexing of the lug 72 is promoted. The hinge or pivotportion 76 may optionally be defined by a thinned portion 78 (or someother material weakening) of the lug 72, or at the junction between thelug 72 and the base 70.

The cover 14 may comprise a top wall 14 a, and a skirt 14 b around thetop wall 14 a. The top wall 14 a and the skirt may be integral, or theymay be distinct parts assembled together. The first member 18 is movablysupported by a bracing portion 80 of the cover 14. The bracing portion80 is of closed loop shape and depends from, e.g., the skirt 14 b of thecover 14. In FIG. 9, the first (appliance coupling) member 18 is shownseparated from (or floating with respect to) the cover 14 and bracingportion 80, but FIGS. 12 and 13 show the first member 18 in a firstunlocked position with respect to the bracing portion 80, and FIG. 14shows the first member 18 in a second locked position with respect tothe bracing portion 80. The degree of axial overlap between the bracingportion 80 and the first member 18 controls the degree to which the lugs72 are free to flex to permit engagement or disengagement of thebody-side coupling member 54 with respect to the first member 18. In thefirst unlocked position, the lugs 72 are not substantially blocked bythe bracing portion 80, and the lugs are relatively free to flexoutwardly. In the second locked position, the lugs 72 are substantiallyblocked or braced by the bracing portion 80, effectively locking thelugs 72 against flexing outwardly.

The first member 18 is retained captive relative to the bracing portion80 by co-operating retainers (e.g. 82-88 in the present embodiment)provided at least one on the first member 18 and at least one on thebracing portion 80 (or other portion of the cover 14). Functions of theretainers may include one or more of:

(i) retaining the first member 18 and the bracing portion 80 of thecover 14 (second member) initially in the unlocked position with a firstretention strength until pressure is applied to cause relativedisplacement to the locked position; and

(ii) retaining the first member 18 and the bracing portion 80 of thecover 14 (second member) in the locked position with a second retentionstrength.

The second retention strength may optionally be greater than the firstretention strength. One or both retention strengths may depend onwhether or not the first member 18 is engaged with the body-sidecoupling member 54, as such engagement may restrict flexibility ordeformability of the first member 18.

Various arrangements of retainers are envisaged. Purely by way ofexample, in the present embodiment, the retainers include one or moreof:

(a) first retainers 82 in the form of bead segments depending from thebase 70 and interspaced between the lugs 72. The first retainers 82project radially outwardly beyond the base with an overlappingstaircase-like profile. The lugs 72 and first retainers 82 alternate ina peripheral direction, around the periphery of the first member 18.Gaps 90 may be provided between the confronting edges of the firstretainers 82 and the lugs 72.(b) second retainers 84 in the form of flange-like or fin-like segmentsprojecting from the base 70, at a level spaced from the first retainers82 by an axial separation 92. The second retainers 84 are aligned withthe pitch positions of the lugs 72, but project radially outwardly ofthe base 70, for example. The second retainers 84 each have a lengththat is generally equal to the spacing between consecutive firstretainers 82, which facilitates molding. Alternatively, the secondretainers 82 could be of other length(s), or merged together into asingle second retainer (not shown) extending as a substantiallycontinuous fin or flange around the entire periphery of the base 72,although this might require a more complex molding tool.(c) third retainers 86 at the tip of the bracing portion, and defininginwardly directed teeth or castellations. The third retainers 86 havepitch positions corresponding to the pitch positions of the lugs 72,such that the third retainers 86 may overlap the second retainers 84corresponding to each lug 72. Each third retainer 86 may also have anangular length in the peripheral (e.g. circumferential) direction thatis longer than the spacing of consecutive first retainers 82, such thateach third retainer may also overlap the ends of the two first retainers82 on either side of a respective lug 72.(d) a fourth retainer 88 in the form of a radially inwardly directedannular shoulder of the bracing portion 80.

The cooperation between the retainers 82-88 is as follows:

When the first member 18 is in the first unlocked position (FIGS. 12 and13), the first and second retainers 82 and 84 generally overlap with,and engage opposite faces of, the third retainer 86. The third retainerhas an axial thickness that is not greater than the spacing 92. Thefirst retainers 82 engage or confront a body-facing side 94 of the thirdretainer 86, and the second retainers 84 engage or confront an oppositenon-body-facing side 96. This engagement supports and retains the firstmember 18 in the first unlocked position with the first retainerstrength, until a force is applied in a first direction 98 exceeding thefirst retainer strength, to displace the first member 18 relative to thebracing portion 80 towards the second locked position.

When the first member 18 is displaced to the locked position (FIG. 14),the fourth retainer 88 functions as a stop that engages the firstretainer 82 to limit the extent of the displacement. The second retainer84 snaps over and engages behind the third retainer 86. In effect, thesecond retainer 84 moves from engaging the body-facing side 94, to thenon-body-facing side 96 of the third retainer 86. The new engagementbetween the second and third retainers 84 and 86 retains the firstmember 18 in the second locked position with the second retainerstrength. The relative magnitudes of the first and second couplingstrengths may be determined by the shapes of the first and thirdretainers 82 and 86, respectively. For example, the faces that engagewhen in the first unlocked position may have a smaller overlap and/or alarger degree of ramping or rounding, compared to the faces that engagewhen in the second locked position. Such shaping may define the firstretention strength to be smaller than the second retention strength.

Having described the engagement between the first member 18 and thebracing portion 80 of the cover 14, the engagement between the firstmember 18 and the body-side coupling member 54 is now described. Manydifferent designs of interengaging profiles for the first couplingmember 18 and the body-side coupling member 54 may be used that providea press fit (press-together) engagement and/or disengagement when thefirst member 18 is not substantially braced by the bracing portion 80(first unlocked position), and a secure locked-together engagement whenthe first member 18 is substantially braced by the bracing portion 80(second locked position). In the presently preferred embodiment, thebody-side coupling member 54 generally comprises an upstandingcylindrical wall 100 having at its distal end the annular bead 58projecting radially outwardly, and a seal portion 102 directed generallyinwardly. The leading edge of the annular bead 58 includes a rounded orramped lead-in surface 104.

The first member 18 consists of an annular channel that is open towardsthe body-side coupling member 54. The channel includes the base 70, agenerally continuous inner wall 106 depending from the base 70, and agenerally discontinuous outer wall defined by the combination of thelugs 72 and the first retainers 82 around the periphery of the base 70.The leading edge of each lug 72 also includes a rounded or rampedlead-in surface 108. The inner wall 106 defines a seal seat for engagingthe seal portion 102 of the body-side coupling member 54 in theassembled condition.

In use (FIG. 9), the body fitment 50 is adhered to peristomal skin atthe stoma 12 prior to fitting the appliance 10. The use of a separatebody fitment 50 allows a succession of different appliances 10, andoptionally one or more ostomy pouches (not shown) to be worn involvingfar fewer changes of body fitment 50, and therefore less distress forthe peristomal skin. With the appliance 10 initially in its firstunlocked position (FIG. 12), the appliance 10 is prepared for fitting bybeing held by hand so that the first member 18 faces, and is generallyaligned with, the body-side coupling member 54. From that position, theappliance 10 is fitted by simply pressing the appliance by hand on tothe body fitment 50.

Referring to FIGS. 12 and 13, pressing the appliance 10 causes the tipof the cylindrical wall 100 to enter the channel profile of the firstmember 18. Initially, the lead-in surfaces 104 and 108 of the bead 58and the lugs 72 contact each other, and some of this contact force willalso be applied onwards to the retainers 82 and 86 supporting the firstmember 18 in its unlocked position. However, in the unlocked position,the lugs 72 are not substantially braced, and have a weaker resistancethan the first retention strength. The result is that the lugs 72 maydeflect or flex outwardly under relatively low contact force beforethere is much tendency for the first member 18 to move out of theunlocked position. The lead-in surfaces 104 and 108 bearing on eachother therefore cause the lugs 72 to flex, allowing the bead 58 to passover and engage behind the tooth 74 of each lug 72 (FIG. 13). The leadin surfaces 104 and 18, and/or the lack of significant resistance of thelugs 72, contribute significantly to a low press-fit assembly force.

Once this initial stage of engagement has been reached, the retainers 82and 86 become subjected to the full force of the appliance 10 beingpressed on to the body fitment 50. The full force exceeds the firstretention strength, causing the first coupling member 18 to displaceinto the cover 14, from the first unlocked position to the second lockedposition (FIG. 14). In the locked position, the bracing portion 80substantially prevents outward flexing or deflection of the lugs 72,thereby locking the engagement between the first member 18 and thebody-side coupling member 54. The body-side coupling member 54 istherefore trapped in engagement with respect to the first member 18, andthe appliance securely fastened to the body fitment 50.

It will be appreciated that the above two-stage coupling action usingthe first member 18 and the bracing portion 80 of this embodimentachieves several significant advantages:

(i) The appliance is attached using a straightforward press-fit action,not requiring manipulation of any separate or additional locking device.Full locking engagement is achieved upon simple press-fitting. Althoughthere are two separate stages of engagement, the user is unaware becauseone stage follows immediately from the previous stage under the samepress-fit force.(ii) The appliance is attachable using merely a relatively low assemblyforce for press-fitting the appliance to the body fitment, while thefirst member is in the unlocked position. The low assembly force doesnot compromise the final security of the attachment.(iii) The final security of attachment is defined at least partly by theeffect of the bracing portion that braces the first member when thefirst member is displaced to the locked position. This enables asignificantly greater coupling strength than would be achieved using aconventional press-fit coupling assemblable by similar assembly force.In particular, the coupling strength is eminently suited forwithstanding the seal support and/or reaction forces encountered in acontrolled discharge ostomy appliance including a seal pressing on thestoma. This may include the additional dynamic seal force that mayresult from the damping effect described in the first embodiment.

At least one (or each) third retainer 86 may optionally be shaped toinclude a guard portion (not shown) at a position corresponding to arespective lug 72. The guard portion projects radially inwardly to agreater degree than the remainder of the third retainer 86. The guardportion is dimensioned to more tightly brace the lug 72 than theremainder of the third retainer 86, thereby enhancing or guarding thebracing effect. The guard portion is dimensioned so that it does notextend to overlap with the first retainers 82, and so it does notinterfere with displacement of the first member 18 from the firstunlocked position to the second locked position.

It will be appreciated from the foregoing description that the correcttwo-stage engagement may depend on the first member 18 being in itscorrect (first) unlocked position prior to fitting of the appliance 10to the body fitment 50. In one form, the first member 18 is made ofplastics of a significantly and/or strikingly different color from thecover 14 so that the relative position of the first member 18 can easilybe ascertained from a visual inspection. For example, the cover 14 maybe of a skin-like color, such as a light brown or fawn, or the cover 14may be of a neutral color such as translucent. The first member 18 maybe colored to have a contrasting color such as a primary color (e.g.blue or red). In the initial unlocked position (any of FIGS. 2, 5-7, 12,13), which is the correct position prior to fitting, the first member 18should project significantly beyond the bracing portion 80, and so thecontrasting color of the projecting first member 18 should be easilyvisible from a side view of the appliance. If the contrasting color isnot visible, this may indicate that the first member 18 may haveaccidentally been displaced to the locked position. Either the usershould attempt to correct the position of the first member 18 (if thedesign of the appliance permits this), or the user should dispose of theappliance (or return it for refurbishment) as being not suitable foruse.

Similarly, after fitting, the first member 18 should be correctly in itslocked position (FIGS. 8 and 14). In the locked position, the firstmember 18 is substantially shrouded by the bracing portion 80 of thecover 14. By viewing the appliance 10 after fitting (e.g. lookingdownwardly at a side view of the appliance, possibly with the aid of amirror to see other sides of the appliance), the contrasting color ofthe first member 18 should not be substantially visible. If thecontrasting color is visible, this may indicate that the first member 18has not been displaced fully to its locked position, meaning that theappliance might not be securely attached. The user can either try tore-apply pressure to press the appliance 10 progressively at differentperipheral positions to correct the attachment, or the user may removethe appliance 10 knowing that the fitting was not correct.

The above use of contrasting color for the first member 18 can thereforeprovide important indications of the state of the appliance, allowing auser to visually ascertain the state quickly, easily and intuitively. Inthe vast majority of cases, no remedial action will be needed, and theidentification of the operation state is merely to confirm to the userthat the appliance 10 is functioning correctly. The identification ofthe operation state may also aid in the training of an ostomate tocorrectly use the appliance 10.

Referring to FIGS. 1-4, a further optional feature of the preferredembodiment is the provision of a protector 40 initially fitted to theappliance 10 to protect the body-side facing components of the appliance10 prior to the appliance 10 being used. As in the first embodiment, theprotector 40 typically has the form of a shield. The protector 40extends to cover substantially the entire body-side facing side of theappliance 10. The protector 40 is releasably coupled to the appliance 10by means of fastener lugs 42 that engage the periphery of the cover 14,to form an integral assembly.

The protector 40 comprises one or more sections selected from: aperipheral rim 44, an annular step 46, and a coupling member guardportion 49. The present embodiment comprises all three sections, theannular step extending radially inwardly of the rim 44, and the guardportion 49 being disposed radially inwardly of the step 46. Thedifferent sections are integrally formed as a one-piece plasticsmolding. The lugs 42 project inwardly from the rim 44, and defineundercuts with respect to the annular step 46. The guard portion 49serves to protect the first member 18. The guard portion 49 is spacedfrom the first member 18 to isolate the first member from impacts orother external forces received from the body-facing side, that mightotherwise risk displacing the first member 18 to is locked position. Theprotection portion 49 is of a material thickness and/or shape to give ita generally rigid or stiff, self supporting form. For example, the guardportion 49 may include ribs 49 a or other reinforcement shape. The guardportion 49 may have the form of a channel-shaped fender, and extend in aclosed loop to define a closed loop channel. The protector 40 isseparated from the appliance 10 prior to fitting the appliance.

The invention envisages various possible designs for releasing orrelaxing the attachment to the body-side coupling member 54 when theuser desires to remove the appliance 10 after it has been used. In oneform (not shown), the cover 14 may be shiftable from the locked positionback to the unlocked position, in order to remove the bracing effect onthe lugs 72, and allow easier separation. However, in the secondembodiment, the appliance 10 includes the following additional features:

(i) a single-use feature of the cover 14 for obstructing attachment ofthe device to the body fitment 50 more than once. The single-use featureoptionally comprises at least one frangible portion 114 of the cover.The frangible portion 114 may extend into or through the bracing portion80. The single use-feature 114 is optionally associated with a grippabletab 200(ii) an expandable/collapsible waste collector 116 having an entranceopening sealed to the first member 18, to define an entry for stomalwaste once the sealing effect is removed. The waste collector 116 isalso sealed to the cover 14, for example at an opposite end. The portionsealed to the cover 14 may be closed, or it may be open to facilitateventing of flatus through the cover. The waste collector 116 istypically made of flexible plastics film. The waste collector 116 may begenerally tubular, although many other shapes are possible.

In an initial state of the appliance 10 ready for fitting at a stoma 12,the waste collector 116 is folded to a collapsed state (FIGS. 1-4 and12) in which the waste collector 116 is accommodated within the cover14. The waste collector 116 permits displacement of the first member 18from the unlocked to locked positions, as required for proper fitting ofthe appliance.

In use, when the user desires to remove the appliance 10, the usermanipulates the cover 14 to tear the frangible portion 114. The user maydo this using the tab 200. This relaxes or removes the bracing effect ofthe bracing portion 80 around the first member 18, allowing the cover 14to float relative to first member 18 (FIGS. 9 and 17). Floating thecover 14 away from the first member 18 removes the stoma seal 16 fromthe stoma 12, and distends or deploys the waste collector 116. With theeffect of the stoma seal 16 removed, some stomal discharge may occur,but such discharge is contained by the waste collector 116. The firstmember 18 remains attached to the body-side coupling member 54 to definea contained volume for the stoma discharge, and avoid soiling. Althoughthe strength of attachment between the first member 18 and the body-sidecoupling member 54 is reduced by removal of the bracing portion 80, theremoval of the stoma seal 16 also removes any substantial reactionforces needing to be applied from the appliance 10 through the bodyfitment 50. Therefore, the relatively weak attachment of the firstmember 18 to the body-side coupling member 54 is eminently adequatewhile stomal discharge takes place into the waste collector 116. Oncestomal discharge has stopped, the user may easily separate the firstmember 18 from the body-side coupling member 54 to totally separate theused appliance 10 for disposal. A handle 118 may be provided on thefirst member 18 to facilitate peeling the first member 18 from thebody-side coupling member. The handle 118 may be implemented as anintegrally formed tab or extension of the first member 18. In normal useof the appliance (e.g. in the first unlocked, and/or second lockedposition, see FIGS. 1, 2, 7 and 8), the handle 118 is shrouded by thecover 14, and only becomes accessible once the cover 14 has been floatedfrom the first member 18. The bracing portion 80 of the cover 14 mayinclude a recess or clearance for accommodating the projecting handle118.

The single-use feature preferably prevents any attempt to reuse theappliance 10. Depending on the design of the appliance 10, the seal 16in particular may be intended to be used reliably only a single time,and it may be difficult to clean a used appliance 10 to the properdegree of hygiene and sterility. The waste collector may also bedifficult to collapse to a tightly folded condition that does notimpinge on the seal face.

Protector for Accommodating Both Seal Displacement and Movable CouplingMember

The preferred embodiment combines both the aspect of seal displacement,and the aspect of a movable coupling member. The combination placesadditional design constraints on the protector 40. Referring to FIG. 1,it will be appreciated that the seal displacer 48 neighbors the couplingmember guard portion 49 for protecting the coupling member 18. The twoportions 48 and 49 of the protector have opposed design constraints. Theseal displacer 48 is intended to be manipulated and displaced by a userwithout too much effort. In contrast, the guard portion 49 is intendednot to be deformed, as any deformation might risk pressure being appliedaccidentally to the coupling member 18 that could displace the couplingmember 18 to its incorrect locked position.

As best seen in FIG. 2, the guard portion 49 is configured to besubstantially rigid. The rigidity is aided by plural reinforcing ribs 49a. Each rib 49 a extends in a generally radial direction to resistcollapse of the guard portion 49.

The guard portion 49 and the seal displacer 48 adjoin one another at aninterface portion. The interface portion includes a movable or bendableportion (such as one or more folds, or corrugations) that permitsdisplacement of the seal displacer 48 without interfering with the guardportion 49. The seal displacer 48 of the interface portion mayoptionally include an overcentered portion that tends to flip between afirst limit position (corresponding to the fully deployed state of theseal 16), and a second limit position (corresponding to the non-deployedposition of the seal 16).

In addition, the protector 40 serves to brace the single-use frangibleportion 114 of the skirt 14 b, to prevent any accidental tearing of thefrangible portion 114, or lifting of the tab 200, prior to first use. Ascan be seen in FIGS. 3 and 4, the rim 44, in combination with theretainer lugs 42 brace the skirt 14 b. As may also be seen in FIG. 2,additional upstand lugs 44 a in the floor of the annular step 46, alsoserve to anchor the skirt 14 b and the bracing portion 80 in apredetermined, supported position with respect to the protector 40, suchthat the skirt 14 b is comprehensively protected by the protector 40.

Modular Construction of Appliance

A further aspect of the preferred embodiment focuses on a modularconstruction of the appliance 10. Referring to FIGS. 1 and 15-17, theappliance 10 generally comprises one or more of:

(i) A first integrated module 130 comprising: the top wall 14 a of thecover; the collapsible waste collector 116; and the first member 18. Thewaste collector 116 depends from the top wall 14 a, and the first member18 depends from the waste collector 116. The waste collector 116includes a first open end sealed to the top wall 14 a, for example nearthe periphery of the top wall 14 a. The waste collector 116 includes asecond open end, corresponding to the waste entrance of the collector116, that is sealed to the first member 18. The first member 18 thusprovides the mouth of the waste collector 116, and the top wall 14 acloses the opposite end. A chamber 138 is defined within the wastecollector 116.(ii) A second integrated module 140 comprising the skirt 14 b (secondmember) of the cover 14. The skirt 14 b is of closed loop shape, andcomprises the bracing portion 80 for cooperating with the lugs (couplingformation) 72 of the first member 18 for bracing the lugs againstoutward deflection. The skirt 14 b includes the frangible portion 114for releasing the bracing effect when the frangible portion 114 isbroken. The frangible portion 114 extends through the bracing portion80.(iii) A third integrated module 150 comprising: the seal support wall28; and the seal membrane 24. The seal membrane 24 depends from the sealsupport wall 28. The seal support wall 28 and the seal membrane 24together defining the seal chamber 30 in which is disposed theresiliently compressible device 26.

The modules 130, 140 and 150 are assemblable together to form a combinedassembly of the appliance 10.

Preferred details of the modules include:

The first module 130 further comprises the deodorising filter 20communicating with outlet apertures 22 in the top wall 14 a. Variousdifferent techniques for mounting the filter 20 are possible. Thepreferred technique is to mount the filter 20, e.g. by welding, to acarrier film of material that is substantially impermeable to flatusgas. The carrier film is itself mounted to the top wall 14 a, e.g. bywelding, at a position outside the periphery of the filter 20. Such aconstruction has two advantages. Firstly, it enables a preferredtechnique of welding to be used, whereas the thickness of the materialsmight make welding impossible to use to join the filter 20 directly tothe top wall 14 a. Secondly, the carrier film defines an outlet plenum154 between the top wall 14 a and the filter 20, allowing for improveddistribution of flatus to outlets 22 that are slightly spaced apart fromeach other, and some are not in register with the filter exit. Thefilter 20 is of a lateral flow type. Flatus enters the filter at itsperiphery (arrows) and flows laterally (e.g. radially inwardly) in thefilter material to exit the filter near its centre (arrows). The carrierfilm includes one or more apertures that communicate with the exit ofthe filter 20 to allow deodorised flatus to enter the outlet plenum 154.

In the third module 150, the resilient device 26 typically comprises apiece of resilient foam material, for example, Polyether PolyurethaneOpen-Cell foam. The foam may have an Indention Force Deflection in therange of 20-40 lb suitable for generating the static component of thestoma sealing force when the foam is compressed against the stoma inuse. At least one face 164 of the foam may have a non-smooth surfacepattern, such as dimpled or with undulations, projections or channels(typically defining surface variations of less than 5 mm in height). Thenon-smooth surface provides small local variation in force appliedthrough the membrane 24 to the stoma 12 in use, to promote separationand evacuation of flatus at the interface between the seal membrane 24and the surface of the stoma 12. In the present embodiment, both facesof the foam member 26 have non-smooth surfaces, in order to allow thefoam to be fitted either way up, thereby simplifying assembly.

The seal membrane 24 comprises two membrane portions 160 and 162. Thefirst membrane portion 160 is of inverted-top-hat shape, for example,comprising an annular flange 160 a from which depends a well 160 bhaving a seal face 160 c. The seal face 160 c may be smooth, or it mayhave a substantially non-smooth surface, for example, with fineundulations, projections or channels (typically defining surfacevariations of less than 1 mm in height, preferably less than 0.5 mm).The non-smooth surface promotes separation and evacuation of flatus atthe interface with the stoma while obstructing passage of liquid and/orsemi-solid stool. The second membrane portion 162 acts as a mountinginterface between the support wall 28 and the first membrane portion160. The second portion 162 is welded (e.g. at 163) to the support wall28, and extends outside the periphery of the support wall 28 (forexample by a small distance less than 10 mm, preferably of the order ofor less than 5 mm). The first membrane portion 160 is welded to thesecond membrane portion 162 outside the periphery of the support wall28. This provides convenient technique for mounting the membrane portion162, which might otherwise require a complicated or intricate weldingoperation if welded directly to the support wall 28. It also allows forincreased separation between the point of welding of the first membraneportion 160 and the edge of the resilient foam 26 placed inside the sealchamber 30 prior to welding, thereby reducing risk of welding damage tothe foam 26 or to the vertical surface of the first membrane portion160. The second membrane portion 162 includes one or more cut-outs 161for permitting the ports 32 a and 32 b to communicate with the interiorof the seal chamber 30.

The seal support wall 28 carries the ports 32 a and 32 b for controllingthe flow of fluid into and/or out of the stoma seal 16. The port 32 a isdefined by a tube or chimney 166 projecting from the support wall 28.The chimney 166 contains a pad of flow restricting material, such asmicroporous material 168, that is held in the chimney 166 by aninterference fit. The port 32 b is comprised of an umbrella valve 170 orother pressure relief valve, mounted on the upper surface of the supportwall 28. The umbrella valve 170 is made of resilient flexible material,and has the form of an open umbrella or mushroom. The valve is normallybiased to bear against and seal a port aperture in the support wall 28.When the pressure under the valve 170 exceeds the pressure reliefthreshold, the pressure overcomes the bias and lifts the valve out ofsealing engagement to open discharge flow. The resilient nature of thevalve 170 recloses the port aperture when the pressure drops below thethreshold. The umbrella valve 170 is partly surrounded and protected byone or more spacer upstands or vertical ribs 172.

The third module 150 is locatable, and assemble to the first module 130,in an operative position at least partly within in the chamber 138 ofthe first module 130. In the operative position, the seal support wall28 is arranged close to the top wall 14 a, leaving a channeltherebetween for venting of flatus. A shaped piece of open-cell foam 176may be disposed in the channel between the seal support wall 28 and thetop wall 14 a. The open-cell foam 176 may act as a phase separator forprotecting the filter 20 from contamination by any liquid or semi-solidstool that might leak undesirably past the stoma seal 16. The pores orcells of the foam tend to trap, or resist entry or passage of, liquidand semi-solid stool, while permitting gas to pass relativelyunobstructed. The space communicates with the chamber 138 around anannular gap 178 between the periphery of the support wall 28 and thewaste collector 116. In use, flatus gas that the stoma seal 16 allows topass into the chamber 138 enters the channel via the annular gap 178.The flatus passes through the open-cell foam, and then through thedeodorising filter 20, and into the outlet plenum 154 before venting toatmosphere via the outlet apertures 22.

The foam piece 176 is shaped with recesses 180 at positions to fitaround the chimney 166, and around the umbrella valve 170 and its spacerupstands 172. The chimney 166 passes through a socket aperture 182 inthe support wall 28 such that the first port 32 a can communicatedirectly with external atmosphere. In contrast, the second port 32 bcommunicates with the vent channel that is covered by the top wall 14 a.Such an arrangement protects the pressure relief umbrella valve 170 frompossible accidental external interference or blockage, ensuring that thevalve 170 can always function as intended to allow at least someinflation fluid to escape from the seal chamber 30 if the pressure istoo high. The spacer upstands 172 act as a guard fence partly around thevalve 170 preventing the edge of the foam piece 176 from interferingwith the valve 170. Additionally or alternatively, the spacer upstands172 function to ensure that, at least in the region of the valve 170,the support wall 28 is always spaced from the top wall 14 a by a spacingat least equal to the height of the upstands 172, thereby providingsufficient clearance height for the umbrella valve 170 to lift and openwhen appropriate. Any inflation fluid discharging through the valve 170into the channel can vent to atmosphere through the filter 20 in thesame manner as flatus.

The first module 130 and the third module 150 are mechanically coupledtogether in the assembled condition by an interference fit between (i)interlocking retainers 184 on the support wall 28 and the top wall 14 a,and/or (ii) the chimney 166 received in the socket 182.

In the second module 140, the central aperture 186 around which theskirt 14 b extends may be circular or non-circular. In the presentembodiment, the aperture 186 is frusto-circular, having one side coveredby a panel portion 188. The panel portion 188 includes a second socketaperture 190 for receiving the tip of the chimney 166 projecting throughthe first socket aperture 182. The top wall 14 a of the first module 130may have a generally planar upper surface, but in the preferredembodiment, the top wall 14 a has a stepped upper surface, including aslightly proud portion 192. The proud portion 192 has a shape to matchthe frusto-circular shape of the aperture 186 such that, when the secondmodule 140 is assembled around the first module 130, the proud portion192 fits within the aperture 186, and is substantially planar with thepanel 188. The top wall 14 a and the skirt 14 b thus form anintegral-like assembly, with a flat upper surface. The second module 140and the first module 130 are mechanically coupled together in theassembled condition by a mechanical interference fit between (i) thechimney 166 of the second module 150 assembled to the first module 130and projecting through the second socket aperture 190, and/or (ii)inter-fitting retainer formations (not shown) around portions of theperiphery of the proud portion 192 of the top wall 14 a, and theperiphery of the aperture 186 of the skirt 14 b.

The frangible portion 114 is associated with the lift-to-open tab 200integrated into the skirt 14 b. The tab 200 is delimited on either sideby grooves 202 in the skirt 14 b. The frangible portion 114 isimplemented at at least one of the grooves 202. In normal use of theappliance 10, the lift-to-open tab 200 forms part of the closed loopshape of the skirt 14 b. Later, when the user desires to float the cover14 from the first member 18, the user applies finger pressure tomanipulate the tab 200. Manipulation of the tab 200 distorts theplastics material of the skirt 14 b as the tab 200 is bent upwardly. Themanipulation tears through the frangible portion 114, splitting theclosed loop shape of the skirt 14 b to form a split (not closed) loop.Splitting the skirt 14 b removes the bracing effect of the bracingportion 80, thereby allowing the cover 14 to float free of the firstmember 18, while remaining captive to the first member 18 by the wastecollector 116. The portions that float free as an integral assemblyinclude one or more of: the split skirt 14 b, the top wall 14 a, theseal support wall 28, and the seal 16.

To produce the appliance 10, the modules 130, 140 and 150 are assembledin any order as desired. During assembly, the foam piece 176 is arrangedbetween the top wall 14 a and the seal support wall 28. The foam piece176 might not be an integral part of any individual module (although itis shown in FIG. 16 associated with the third module 150 for ease ofunderstanding). The foam piece 176 is retained captive once the modulesare assembled together. Also during assembly, the waste collector 116 iscollapsed down to its stowed form, in which the waste collector 116 istightly accommodated in the space just radially inside the bracingportion 80.

It will be appreciated that the modular construction of the appliance 10can enable a complicated and compact ostomy appliance to be producedeconomically and reliably. Each module 130, 140, 150 is relativelystraightforward to manufacture as an individual item. The relativelycomplicated appliance is then produced by assembling the modulestogether.

It will also be appreciated that the foregoing description is merelyillustrative of a preferred embodiment of the invention, and does notlimit the invention. Many alternatives, equivalents and improvements maybe made within the scope and/or spirit of the invention.

The invention claimed is:
 1. A controlled discharge ostomy applianceassembly comprising: (a) a controlled discharge ostomy appliance havinga body-facing side and comprising: a cover; a body fitment; a stoma sealdisposed within the cover, and a first coupling member configured forcoupling to the body fitment configured for mounting the controlleddischarge ostomy appliance in an operative position at a stoma, thefirst coupling member being displaceable with respect to the cover froman unlocked position to a locked position; and (b) a protector shieldconfigured for protecting the body-facing side of the controlleddischarge ostomy appliance, the protector being made of integrallymolded plastics and comprising: a substantially rigid coupling memberguard portion configured for protecting the first coupling member of thecontrolled discharge ostomy appliance from external forces capable ofdisplacing the first coupling member from the unlocked position to thelocked position, and a fastener configured for co-operating with thecontrolled discharge ostomy appliance at a location distinct from thefirst coupling member, to fasten the protector to the controlleddischarge ostomy appliance releasably to form a combined assemblytherewith.
 2. The controlled discharge ostomy assembly of claim 1,wherein the protector shield further comprises a seal displacerconfigured for displacing the stoma seal from a deployed position to anon-deployed position.
 3. The controlled discharge ostomy assembly ofclaim 1, wherein: (a) the controlled discharge ostomy appliance furthercomprises a second coupling member including a frangible portion that isbreakable or tearable in use for releasing the controlled dischargeostomy appliance from the body fitment; and (b) the protector shieldfurther comprises a bracing portion for bracing and supporting thesecond coupling member of the controlled discharge ostomy appliance, toprevent tearing of the frangible portion prior to first use.
 4. Acontrolled discharge ostomy appliance assembly comprising: (a) acontrolled discharge ostomy appliance having a body-facing side andcomprising: a stoma seal, and a member including a frangible portionthat is breakable or tearable in use configured for releasing at leastone of (i) the stoma seal from an operative position; and (ii) thecontrolled discharge ostomy appliance from a body fitment; and (b) aprotector shield configured for protecting the body-facing side of thecontrolled discharge ostomy appliance, the protector being made ofintegrally molded plastics and comprising: a bracing portion configuredfor bracing and supporting said member of the controlled dischargeostomy appliance, to prevent tearing of the frangible portion prior tofirst use, and a fastener configured for co-operating with thecontrolled discharge ostomy appliance, to fasten the protector to thecontrolled discharge ostomy appliance to form a combined assemblytherewith.
 5. The controlled discharge ostomy assembly of claim 4,wherein the protector shield further comprises a seal displacerconfigured for displacing the seal of the controlled discharge ostomyappliance from a deployed position to a non-deployed position.
 6. Aprotector shield for protecting a body-facing side of a controlleddischarge ostomy appliance, the protector shield being made ofintegrally molded plastics and comprising: (i) a protector; (ii) a sealdisplacer configured for displacing a self-urging seal of the controlleddischarge ostomy appliance from a deployed position to a non-deployedposition, (iii) a substantially rigid coupling member guard portionconfigured for protecting a first coupling member of the controlleddischarge ostomy appliance from external forces capable of displacingthe first coupling member from an unlocked position to a lockedposition, (iv) a bracing portion configured for bracing and supporting asecond coupling member of the controlled discharge ostomy appliance, thesecond coupling member including a frangible portion that is breakableor tearable in use to release the controlled discharge ostomy appliance,and (v) a fastener configured for co-operating with a periphery of thecontrolled discharge ostomy appliance, to releasably fasten theprotector shield to the controlled discharge ostomy appliance to form acombined assembly therewith.
 7. The protector shield of claim 6, whereinthe seal displacer is located at a centre of the protector.
 8. Theprotector shield of claim 6, wherein the coupling member guard portioncomprises a channel shaped fender, the fender extending in a closed loopto define an endless channel.
 9. The protector shield of claim 6,wherein the coupling member guard portion extends around the sealdisplacer.
 10. The protector shield of claim 9, wherein the sealdisplacer and the coupling member guard portion adjoin at a bendableinterface portion.
 11. The protector shield of claim 6, wherein thebracing portion comprises a step-shaped recess extending around a closedloop shaped path.
 12. The protector shield of claim 6, wherein thefastener comprises at least one undercut lug.